Estimating the expected performance and monitoring the actual performance of clinical laboratory testing and diagnostic systems requires detailed and current information. Clinical laboratory testing and diagnostic systems include many components and subsystems in a complex coordinated combination for carrying out accurate assays while maintaining a high throughput. As example is provided by the VITROS 5600™ and ECi line of clinical Diagnostic Analyzers manufactured by Ortho Clinical Diagnostics (“OCD”) of Raritan, N.J.
Laboratories differ significantly in their use of laboratory testing and diagnostic systems. Physicians need fast turnaround times for results to allow them to effectively monitor patients under care. For instance, patients with kidney problems or trauma need to be evaluated and monitored to properly manage their electrolyte levels. Further, local needs result in different mixes of tests in different clinical laboratories, which may require customized approaches for evaluating analyzer performance.
Testing to ensure a high level of reliability preferably includes monitoring aimed at both quick servicing times and improving analyzer performance. To this end, an embedded controller is often relied upon to periodically provide data and to log the huge number of events reflecting analyzer operation. This data is uploaded at a fixed time, for instance, at mid-night, and the like. Such data is not only stale but voluminous making the task of analyzing events of interest tedious.
Embedded controllers, also referred to as “embedded devices”, in a clinical diagnostic analyzer are often connected to an internal network, such as a local area network (LAN), wireless IEEE (Institute of Electrical & Electronics Engineers) 802.11, wireless broadband, or HomePlug powerline, with an interface to the Internet. The embedded device is typically behind a firewall, which prevents it from being addressed or discovered directly by an external monitoring system.
This limitation on the use of embedded devices is expected due to the need to keep networks secure and protect patient data. As a result, it is difficult, if not impractical, to freely monitor a clinical diagnostic analyzer installed at a remote site. Some monitoring approaches have been proposed, some of which balance the need to monitor against the requirement to maintain a secure environment for sensitive data.
U.S. Pat. No. 6,768,968 (the “'968 patent”) discloses a strategy for estimating the performance of a computer system. While a clinical diagnostic analyzer includes processing power, it is not quite like a computer system in view of its highly specialized properties. The '968 patent discloses some monitoring strategies without adequate consideration of the privacy needs. The computer in a diagnostic analyzer is integrated with electrical and mechanical parts for accurately testing biological materials—the primary purpose of the device. This integrated design is susceptible to failures that are not analogous to those experienced by computer systems.
U.S. Pat. No. 7,254,601 (the “'601 patent”) discloses a method for managing remotely deployed intelligent equipment by establishing a direct computer-based connection to remote equipment through Internet standard protocols and a Gateway, which masquerades for a set of assets, translates addresses, and provides necessary protocol conversions needed to “speak the native language of the enterprise.” The '601 patent discusses the need to get past firewalls noting that most firewalls permit HTTP traffic, the protocol used by browsers to retrieve web pages, which access may be used to provide web services based on text messages formatted with eXtensible Markup Language (XML), to package requests as messages. Some such standards include WSDL (Web Service Description Language), SOAP (Simple Object Access Protocol), and XML. The disclosure does not, however, teach providing real-time alerts.
U.S. Pat. No. 6,377,162 (the “'162 patent”) discloses a field service unit for providing interactive field service of medical diagnostic systems generating images. The '162 patent does not disclose or address the failures encountered by clinical diagnostic analyzers because it is focused on systems generating images, such as resulting from X-ray scans.
US Patent Publication No. 2007/0288629 (the “'629 publication”) discloses sending fault information outside of a firewall by periodically sending a polling call to an enterprise system outside the firewall at a first polling rate during normal operating conditions, and sending polling calls to the device outside the firewall at a second polling rate in response to detecting a fault condition. The second polling rate is higher than the first polling rate. The method includes sending a problem report with the polling calls when the fault condition is detected. Sending the request from within the firewall allows opening of a two-way connection through the firewall between the device inside the firewall and the external system. However, in the absence of a polling message from inside the firewall, the embedded device remains undiscoverable by the systems outside the firewall.
U.S. Pat. No. 6,757,714 (the “'714 patent”) and patents and patent applications related thereto disclose obtaining and communicating an error condition of an apparatus—via email to a remote server. A predefined template is used to generate the e-mail message by obtaining and inserting one or more variables into the template. The error condition may be included as part of a body of the e-mail message or as part of an attachment to the e-mail message. The error condition is reported using a self-describing computer language, such as eXtensible Markup Language (XML). In general, the error condition is determined with the aid of an embedded controller. The remote server passes the error condition to a customer relationship management system.
In the '714 patent's disclosure, e-mail allows the remote server to obtain information about the apparatus even if the remote server cannot directly address the embedded controller. Email can provide information, for instance if the remote server is not on the same internal network as the embedded controller. Moreover, because the error condition is reported using XML, the remote server may automatically schedule maintenance. As may be expected, the emails in such a system contain state information for extraction by the monitoring system. The '714 patent limits error notifications to detecting predefined events with no ability to customize alerts to detect other than predefined events.
Another option for monitoring clinical diagnostic analyzers is to transmit a program to the target analyzer to reprogram it. Programming a remote device using XML coding is described in U.S. Pat. No. 7,178,149. Such programming, however, significantly increases the complexity of the task of monitoring the analyzers because each command of the programming language is made to correspond to a tag in XML with the overhead of XML added to make the transmitted program code quite voluminous. At the target device, the XML encoded program may need to be not only decoded, but potentially also compiled and run. Thus, the overhead at the target remote device is also significantly higher. XML itself is merely a text transmission method in such an implementation, no different from sending an email containing program code. These considerations make this approach unsuitable for customized remote monitoring of a clinical diagnostic analyzer.
Alternatively complex circuits and functionalities can be implemented to monitor a networked device in a distributed system such as those described in U.S. Pat. No. 6,892,317. This would not work, however, with clinical diagnostic analyzers in different networks protected by firewall. Thus, there is a need for better monitoring of clinical diagnostic analyzers.